References - Travel and Leisure

Have you ever thought "I wonder what white water rafting is like?" I know I have. And I think I kind of thought "Yeah, I'd like to try it." But another part of me, the scared chicken part of me thought "HA!! You turned 60 years old last winter. Who are you trying to kid?"

And then..

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

. My older (but not necessarily wiser) sister Sue stopped by one day quite excited. She had won a raffle and the prize was four whitewater rafting tickets.

She had decided that as long as she was turning 65 in a few days she was going to have a coming out party and invite all her sist

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

rs to go with her on a whitewater rafting trip. Was I interested? "Yes!!" I answered automatically and enthusiastically. All of a sudden fear gripped me. What was I thinking? Whitewater rafting??

Sister Jeanette was psyched. She's the youngest and is quite adventurous. Sister-in-

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

law Mary asked if her hair would get wet. Sister Anne said if Mary was going she would. Sister Sam said she was in. Sister Mary lives in Florida and couldn't make it. I guess I'll have to go if everyone else is, I can't be the chicken. Mom worries that her whole family may be wiped

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

ut all at once.

Wednesday we drive two hours through pouring rain that has been coming down nonstop since some time in the night to our hotel in Indian Lake. We hope it will stop raining by Thursday and wonder how this will affect the whitewater rafting?

At night we laugh and drink be

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

ers in the motel reminiscing on when we were kids. Morning brings welcome sunshine.

As the guides explain our part in the whitewater rafting and dangers of the trip, we nervously squeeze into a wet jacket, splash jacket, life vest, and helmet. Our guide shows us her bruises and cuts f

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

om last week when she was hit by a paddle and thrown out of the raft.

It's now apparent that I won't be sitting on a seat in the raft holding on for dear life with my arthritic hands. We have to paddle and we have to sit on the side of the raft with our feed tucked under the things whe

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

re the seats should be. We're asked to sign a release that we won't hold them responsible if we die on this trip.

I'm wondering how big a mistake this was and Anne is really grumbling. We help load the raft onto the school bus for the bumpy ride to the white water. I feel sick.

We c

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

rry the heavy raft from the bus to the water. Couldn't they park any closer? There are hundreds of people here carrying rafts down to the river. I can't believe this many people are here today for whitewater rafting. They're all excitedly talking about how great the water is today.

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

This worries me.

Our guide Josh is cool. We ask if we'll get to try out the paddling before we start out into the white water. "Sure" Josh says, but two forward commands, one backward command, and one left back command and we're out in the white water swinging our paddles and on our w

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

y down the river.

Our paddles all clunk against each other as Josh screams out "Forward!! Paddle Forward!! HARD!! You've got to get it together!!" The front of the raft drops severely as a huge wave pours over the front and into the raft. We all scream in unison. The front rises hi

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

gh into the water and the rear bounces as we cling with our toes. What a rush!!

Everyone is still in the raft. Good. I go over it again in my mind - what to do if someone does fall out of the raft.

1. Reach down and grab them with two hands and pull them in.

2. If they're out too

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

far, reach out with the paddle offering them the handle.

3. If they're out too far, throw the rope bag.

BIGGEST RULE - NEVER NEVER stand up. Keep your feet up if you end up in the river.

We paddle, we rest, we paddle, we drift downstream. Rapids ahead - Grade 3. What does that mea

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

n? BAD?? Josh explains that white water is rated 1-5 with 5 being the kind of water you only went into if you are a professional. The Grade 3 was some pretty good white water.

I feel sick again. There it is ahead. Wow!! Tighten your toes and "Paddle Forward HARD!!" Josh yells. Hu

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

e waves hit us hard on the left side. Buckets of cold water rush over the side covering me and my sisters. We scream in unison. "Paddle Forward HARD!! Forward!!" Josh screams. Our paddles clunk.

We get past the rapids and drift when Anne says she can't take the front any more. She

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

and Sue trade with two adventurous teenagers and thankfully move to the rear.

By the time we pull over for lunch we've been hit by huge waves from every direction. Everyone is soaked. Everyone is tired. Everyone is starving. Our legs don't work well when we get on the rocks. But it

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

s a beautiful sunny day and we just lived half way through an adventure and we're excited.

The guides brought turkey sandwiches, chips and cookies to eat with 5 gallon containers of drinks. They forgot the cups so we drink the water and iced tea from potato chip bags as we sit on the w

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

arm rocks and think about what the rest of the trip holds in store.

The rest of the trip was equally exciting and the water was so fast the trip was two hours quicker than Tuesday of that same week. I loved it! It was a blast. Jeanette, Sam and I will surely do it again. But if you

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

sk Anne, she'll say "Never Again." Sue says maybe she'll try something else next time maybe skydiving.

So if you are trying to decide if you are going to try whitewater rafting ask yourself if you're open to adventure. I really don't like getting cold, especially wet and cold. I worr

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

ied that the cold water would keep me from enjoying the trip. But we were so busy and things were happening so fast there was never time to feel cold and you get used to wet. Personally, I would highly recommend whitewater rafting. As I said, it was a BLAST!

Copyright 2006 Alice Scot

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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References - Whitewater Rafting For Beginners

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